Zydus Lifes gets nil observations after USFDA's inspection of Injectables unit in Ahmedabad

Zydus Lifesciences said in the filing on Tuesday that the group’s injectables manufacturing facility at Zydus Biotech Park in Changodar in Ahmedabad underwent USFDA inspection from 5 th June to 13 June 2023. 

The CGMP inspection concluded with nil observations.

Further, the company said it has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg (USRLD: Arthrotec® Delayed-Release Tablets).

The group now has 373 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04, the company said.

Source: Media reports